New prescription drugs follow a rigorous process from compound discovery to final approval requiring many years and many millions of dollars in investment. During clinical trials, much ECG data is acquired from the patients involved in the trial. Typically, these ECGs are reviewed in a “blinded” fashion by the overreader. In other words, the person reading the ECG is completely obscured from the demographic information of the patient and may not have access to the patient's previous ECGs to prevent biasing during the overreading process. While this technique is useful to increase the accuracy of the process, from the patient's perspective it may cause the overreader or trial administrator to miss significant changes in the ECG.
Additionally, in normal hospital or clinical practices, ECGs are typically reviewed in reverse chronological order, in other words, from latest to earliest to look for changes in the ECG. This technique is typically used to look for serial changes common in myocardial infarction and ischemic heart disease. However, it is now understood that many drugs can cause acquired LQTS in patients over time, thus making it useful to have an automated method to detect acquired (drug-induced) LQTS.
Furthermore, congenital LQTS is well understood to be a cause of Sudden Cardiac Death. The prevalence of this condition in the population is typically estimated at 1 in 10,000 patients. However, recent studies have shown that the prevalence and types of mutations between ethnic groups varies and could be much greater than this ratio in some groups. Sudden Cardiac Death kills more than 1000 individuals each day in the U.S. It would be useful to have a system that could identify these patients before an arrhythmic episode.